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使用布地奈德-福莫特罗进行阶梯式治疗的慢性呼吸系统疾病:一项单臂干预性研究。

Stepped treatment algorithm using budesonide-formoterol for chronic respiratory diseases: A single arm interventional study.

机构信息

Woolcock Institute of Medical Research, Hanoi, Vietnam.

South Western Sydney Clinical School, University of New South Wales, Sydney, Australia.

出版信息

PLoS One. 2022 Jul 11;17(7):e0271178. doi: 10.1371/journal.pone.0271178. eCollection 2022.

DOI:10.1371/journal.pone.0271178
PMID:35816478
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9273083/
Abstract

BACKGROUND

While the safety and efficacy of inhaled budesonide-formoterol, used as-needed for symptoms, has been established for patients with asthma, it has not been trialed in undifferentiated patients with chronic respiratory diseases. We aimed to assess the feasibility of a pragmatic intervention that entails a stepped algorithm using inhaled budesonide-formoterol (dry powder inhaler, 160μg/4.5μg per dose) for patients presenting with chronic respiratory diseases to three rural district hospitals in Hanoi, Vietnam.

METHODS

We recruited patients with evidence of airflow obstruction on spirometry and/or symptoms consistent with asthma. The algorithm consisted of three steps: 1. as-needed inhaled budesonide-formoterol for symptoms, 2. maintenance plus as-needed inhaled budesonide-formoterol, and 3. referral to a higher-level healthcare facility. All participants started at step 1, with escalation to the next step at review visits if there had been exacerbation(s) or inadequate symptom control. Patients were followed for 12 months.

RESULTS

Among 313 participants who started the treatment algorithm, 47.2% had ≥ 1 episode of acute respiratory symptoms requiring a visit to hospital or clinic and 35.4% were diagnosed with an exacerbation. Twelve months after enrolment, 50.7% still adhered to inhaled budesonide-formoterol at the recommended treatment step. The mean and median number of doses per day was 1.5 (standard deviation 1.2) doses and 1.3 (interquartile range 0.7-2.3) doses, respectively. The proportion of patients taking more than 800μg budesonide per day was 3.8%.

CONCLUSION

This novel therapeutic algorithm is feasible for patients with chronic respiratory diseases in a rural setting in Vietnam. Further studies are required to establish the effectiveness, safety and cost-effectiveness of similar approaches in different settings.

TRIAL REGISTRATION

ACTRN12619000554167.

摘要

背景

布地奈德福莫特罗按需吸入治疗(干粉吸入剂,剂量为 160μg/4.5μg)已被证实用于哮喘患者安全有效,但尚未在患有慢性呼吸道疾病的未分化患者中进行试验。我们旨在评估一种实用干预措施的可行性,该措施涉及在越南河内的三家农村地区医院为患有慢性呼吸道疾病的患者使用布地奈德福莫特罗分步算法(干粉吸入剂,剂量为 160μg/4.5μg/剂)。

方法

我们招募了肺功能检查显示气流阻塞证据和/或有哮喘症状的患者。该算法包括三个步骤:1.按需吸入布地奈德福莫特罗治疗症状,2.维持治疗加按需吸入布地奈德福莫特罗,3.转至更高一级的医疗机构。所有参与者从第 1 步开始,如果有恶化或症状控制不佳,在复诊时升级到下一步。患者随访 12 个月。

结果

在开始治疗算法的 313 名参与者中,47.2%有≥1 次因急性呼吸道症状需要就诊医院或诊所的发作,35.4%被诊断为恶化。入组 12 个月后,50.7%的患者仍按照推荐的治疗步骤使用布地奈德福莫特罗。每天的平均剂量和中位数剂量分别为 1.5(标准差 1.2)剂和 1.3(四分位间距 0.7-2.3)剂。每天使用超过 800μg 布地奈德的患者比例为 3.8%。

结论

这种新的治疗算法在越南农村地区的慢性呼吸道疾病患者中是可行的。需要进一步研究以确定在不同环境中类似方法的有效性、安全性和成本效益。

试验注册

ACTRN12619000554167。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae0f/9273083/6ce0145ea721/pone.0271178.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae0f/9273083/13174f0f9c0a/pone.0271178.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae0f/9273083/17db0bdcc6c4/pone.0271178.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae0f/9273083/bd373902edfd/pone.0271178.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae0f/9273083/6ce0145ea721/pone.0271178.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae0f/9273083/13174f0f9c0a/pone.0271178.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae0f/9273083/17db0bdcc6c4/pone.0271178.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae0f/9273083/bd373902edfd/pone.0271178.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae0f/9273083/6ce0145ea721/pone.0271178.g004.jpg

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